After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they are marketed. On the basis of experience gathered through a number of collaborative efforts, the Federal Partners’ Collaboration pilot project, involving FDA, the Centers for Medicare & Medicaid Services, the Department of Veteran Affairs, and the Department of Defense, is already enabling FDA to leverage the power of large public health care databases to assess, in near real time, the utility of analytical tools and methodologies that are being developed for use in the Sentinel System. Active medical product safety surveillance is enhanced by use of these large public health databases because specific populations of exposed patients can be identified and analyzed, and can be further stratified by key variables such as age, sex, race, socioeconomic status, and basis for eligibility to examine important subgroups.
*Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring
†Center for Medicare, Centers for Medicare & Medicaid Services (CMS), Baltimore, MD
‡Department of Veterans Affairs, Center for Medication Safety, Pharmacy Benefits Management Services, Hines, IL
§Pharmacovigilance Center, US Army Office of the Surgeon General, Silver Spring, MD
The authors declare no conflict of interest.
Reprints: Melissa A. Robb, BSN, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave, Building 51, Room 6360, Silver Spring, MD 20993. E-mail: email@example.com.